1. Field of Invention
The invention relates to a method for producing an individual concentrate for dialysis with a device that includes a dialysis machine having a compressed air source, a concentrate line, a compressed air line between the concentrate line and the compressed air source, and a concentrate intake rod that is connected to the concentrate line. The method includes thoroughly mixing the first liquid concentrate and the second liquid concentrate in the container by introducing compressed air through the compressed air line, the concentrate line, and the connected concentrate intake rod. The invention also relates to a suitable device for performing the method. The composition of this individual concentrate may be adapted optimally to the specific needs of an individual patient without having to keep a large selection of concentrates on hand in the clinic. Through a system of concentrates that are mixed by machine in an automated process, the labor for the operating personnel and the risk of contamination are reduced.
2. Description of the Prior Art
In the treatment of chronic renal failure, solutions for hemodialysis are often prepared online from concentrates and ultrapure water by a portioning unit of the dialysis machine. The dialysis machine usually receives ultrapure water from a central supply, whereas the required electrolytes in the form of concentrates that are packaged in bags or canisters are made available on the dialysis machine by the nursing staff.
With the bicarbonate dialysis which is customary today, two concentrates are usually needed due to the required electrolyte composition of the solution for hemodialysis or similar methods, namely a basic concentrate which contains the buffer bicarbonate and optionally salt and an acid concentrate which contains the other electrolytes, for example, magnesium, calcium, potassium, glucose and an acid. The basic concentrate is usually supplied as a dry concentrate but may also be made available in the form of a liquid concentrate. The acid concentrate is usually a liquid concentrate. Liquid concentrates are usually supplied in plastic canisters with a volume of 3-10-L canisters. The two concentrates are drawn into the dialysis machine by the concentrate pumps of the portioning unit of the dialysis machine and are diluted with water in a defined ratio in the machine to obtain the desired electrolyte concentration. The resulting electrolyte solution corresponds largely to the composition of physiological, i.e., healthy blood plasma and can then be used for treatment of chronic renal failure by hemodialysis.
Renal failure can be triggered by a number of diseases. In addition, the dialysis treatment itself constitutes a serious intervention in the human body which may cause various complications and co-morbidities. Therefore, the initial situation at the beginning of treatment may vary greatly from one patient to the next. For example, many patients have extremely high potassium levels prior to dialysis. To make dialysis as gentle as possible, the potassium concentration in the dialysate may also be set somewhat higher here. The same thing is also true of the other electrolytes. Whereas most dialysis patients are found to have an excessive phosphate burden, many patients who have undergone dialysis suffer very intensely from hypophosphatemia, which can be relieved by the presence of phosphate in the dialysis solution. Malnutrition is another challenge dialysis patients must often encounter. An improvement can be achieved here by adding glucose or amino acids to the concentrate. In addition, the unintentional removal of trace elements from the blood due to the dialysis treatment can be counteracted, if necessary, by replacement of these trace elements in the dialysis solution. The individual requirements of the precise composition of the dialysis solution used thus cover a wide spectrum, and the individual adaptation of the dialysis solution to the respective needs of the patient can minimize adverse effects and improve the success of the treatment.
On the other hand, storage capacity in a clinic is limited, so that it is only possible to keep on hand a limited number of different dialysis concentrates. At the same time, storing and preparing a great many different concentrates would necessitate complex logistics.
DE 32 24 823 solves this problem by having a modular composition for the concentrate for the solution for hemodialysis. One or more special concentrates as an extra solution containing the desired extra components are added to a stock solution in which the electrolyte composition corresponds approximately to the physiological electrolyte composition of blood, after being diluted by the portioning unit of the dialysis machine. The stock solution is kept in a canister in an amount of nine liters. The extra solutions and/or special concentrates are added in amounts of 10-500 mL. The special concentrates each contain only one component, which is either not present in the stock solution or whose concentration is to be increased in comparison with that of the stock solution.
WO 99/07419 describes the addition of vitamins and trace elements to the liquid bicarbonate concentrate.
However, the concentrate for preparing the solution for hemodialysis must be homogeneous; otherwise safe handling is not ensured. Therefore, in practice today the resulting solution is mixed by intense agitation of the canister by the nursing staff after adding the special concentrate to the acidic or basic concentrate for the bicarbonate dialysis. This means a physical burden for the user. The canister must be opened to add the special concentrate. Before shaking the canister, it must be resealed with the cover. These steps may result in contamination of the concentrate.